DHF for drug products

[Mr. E]

Hello team,

I have a questions to which I have tried to search already without results. What is the equivalent in Pharmaceutical (drug products) for Design History File (DHF).

The closes I was able to find in regulation was 21CFR211.186 Master production and control records, but does not covers Design Files.

Thank you
Mr. E

 

[v9991]

We have addressed this scenario when dealing with DHF combination product ; and answer to that is
to map each of line item of the DHF content in two columns, one for the device itself ; and other for the drug product, at some phase or contents of DHF become common, viz., DT or DV.
i will try place it from perspective of typical ANDA, and the process should be established or evolved as we move away from ANDA perspective ( even if its labelling differences, patent non infringing designs, or new indications, or even improvements. etc )

1. Design Plan - there is seldom a project plan beyond compliance or objective or reference listed drug reference, usually coming from the product development report. ( 32p2 )
2. User Needs - QTPP
3. Design Inputs - CQA
4. Design Outputs - Control Strategy
5. Risk Analysis, Including Hazard Identification - CMA & CPP assessment
6. Human Factors Analysis - NA ( device reference is adequate )
7. Design Verification, With Acceptance Criteria - scale up, pilot bio or bridging studies,
8. Design Validation, With Acceptance Criteria - exhibit/submission batch validation reports
9. Design Changes - Master production records
10. Software Validation—If Applicable
11. Design Reviews - Change control for moving into exhibit batch phase or validation phase.
12. Design Transfer - scale up report.

hope this helps.